Last updated: January 3, 2024
Sponsor: Viome
Overall Status: Active - Recruiting
Phase
N/A
Condition
Anxiety Disorders
Panic Disorders
Kleptomania
Treatment
VIOME Precision Nutrition Program
Control arm
Clinical Study ID
NCT06190184
V211.3.1
Ages > 25 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Resident of the United States
- 50 years old and older OR BMI of 25 or greater
- Able to speak and read English
- No unexplained weight loss, fevers, anemia, or blood in stool
- Willing and able to follow the trial instructions, as described in the recruitmentletter
- Signed and dated informed consent prior to any trial-specific procedures.
- PHQ9 score of 5-24 (inclusive)
Exclusion
Exclusion Criteria:
- Unwilling to change their current diet
- Prior use of Viome products or services
- Antibiotic use in the previous 4 weeks
- Pregnancy (current or planned in the next 4 months)
- < 90 days postpartum
- Breast feeding
- Active infection
- Unable or unwilling to use Viome's App on an iPhone or Android smartphone
- Significant diet or lifestyle change in the previous 1 month
- IBD diagnosis -Major psychiatric/DSM-4 disease diagnosis (e.g. Schizophrenia, Bipolardisorder, Post- traumatic Stress Disorder, Obsessive Compulsive disorder)
- Use of investigational drugs, products or devices within 1 month prior to and 4 monthsafter the start of the trial
- Cancer therapy within the previous 1 year
- Major surgery in the last 6 months or planned in the next 4 months
- Allergies to any supplement ingredients listed in the screening survey
- Currently on a specific diet: FODMAP, KETO, PALEO
- Answered yes to the question, "In the past few weeks, have you wished you were dead orhad thoughts about killing yourself?"
- Gastrointestinal disease including:
- GI surgery except:
- Appendectomy and benign polypectomy
- Esophagitis
- Celiac disease
- GI malignancy or obstruction
- Peptic Ulcer Disease
- Duodenal or gastric ulcer disease
Study Design
Total Participants: 60
Treatment Group(s): 2
Primary Treatment: VIOME Precision Nutrition Program
Phase:
Study Start date:
October 26, 2023
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Viome Life Sciences
Bothell, Washington 98011
United StatesActive - Recruiting
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